View ICR - OIRA Conclusion



0938-1452 202411-0938-010
Active 202307-0938-009
HHS/CMS CM
Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)
Revision of a currently approved collection   No
Regular
Approved without change 01/08/2025
Retrieve Notice of Action (NOA) 11/25/2024
Prior to the submission of the information collection request (ICR) for Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849), CMS will provide an analysis of the 2027 negotiation data submissions from manufacturers including, but not limited to, a meta-analysis of data from sections C: Research and Development Costs, Recoupment and D: Current Unit Costs of Production and Distribution, and E: Prior Federal Financial Support. Also, in its 2028 ICR submission, CMS will address (1) improvements to the agency’s ability to audit manufacturers’ data, (2) revisions to ensure high quality and more consistent data across manufacturers, and (3) reporting burden reductions for manufacturers based on the agency's experience and analysis of the Initial Price Applicability Year 2027 data submissions.
  Inventory as of this Action Requested Previously Approved
01/31/2026 36 Months From Approved 09/30/2025
355 0 10
23,764 0 2,043
0 0 0